Clinical Trials Register

Summary
EudraCT Number:	2021-004934-12
Sponsor's Protocol Code Number:	INCB54828-210
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-03-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2021-004934-12

A.3

Full title of the trial

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced Non–
Small Cell Lung Cancer With an FGFR Alteration Who Progressed on Previous Therapy (FIGHT-210)

Studio multicentrico di fase 2, in aperto, a braccio singolo per valutare l’efficacia e la sicurezza di pemigatinib in partecipanti con carcinoma polmonare non a piccole cellule in stadio avanzato con alterazione di FGFR, che hanno manifestato progressione durante una terapia precedente (FIGHT-210)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A.3.2

Name or abbreviated title of the trial where available

FIGHT-210

A.4.1

Sponsor's protocol code number

INCB54828-210

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	INCYTE CORPORATION
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Incyte Corporation
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Incyte Corporation
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	1801 Augustine Cut-Off
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	DE 19803
B.5.3.4	Country	United States
B.5.4	Telephone number	000000
B.5.5	Fax number	+13024252734
B.5.6	E-mail	RA@incyte.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pemazyre
D.2.1.1.2	Name of the Marketing Authorisation holder	Incyte Biosciences Distribution B.V.- EU/1/21/1535/003
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pemigatinib
D.3.2	Product code	[INCB054828]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEMIGATINIB
D.3.9.1	CAS number	1513857-77-6
D.3.9.2	Current sponsor code	INCB054828
D.3.9.4	EV Substance Code	SUB194579
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pemazyre
D.2.1.1.2	Name of the Marketing Authorisation holder	Incyte Biosciences Distribution B.V. - EU/1/21/1535/001
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pemigatinib
D.3.2	Product code	[INCB054828]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEMIGATINIB
D.3.9.1	CAS number	1513857-77-6
D.3.9.2	Current sponsor code	INCB054828
D.3.9.3	Other descriptive name	INCB054828
D.3.9.4	EV Substance Code	SUB194579
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Pemazyre
D.2.1.1.2	Name of the Marketing Authorisation holder	Incyte Biosciences Distribution B.V. - EU/1/21/1535/005
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Pemigatinib
D.3.2	Product code	[INCB054828]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PEMIGATINIB
D.3.9.1	CAS number	1513857-77-6
D.3.9.2	Current sponsor code	INCB054828
D.3.9.4	EV Substance Code	SUB194579
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	13
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Male and female participants at least 18 years of age who have squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatment options

Partecipanti di sesso maschile e femminile di almeno 18 anni di età con NSCLC squamoso o non squamoso con mutazioni o fusioni/riarrangiamenti documentati di FGFR1-3 che hanno manifestato progressione durante precedenti terapie e non hanno a disposizione opzioni terapeutiche standard

E.1.1.1

Medical condition in easily understood language

Lung cancer participants with documented FGFR1-3 mutation, who have progressed on prior therapies and have no available standard treatment options

Partecipanti con carcinoma polmonare con mutazione documentata di FGFR1-3 che hanno manifestato progressione durante precedenti terapie e non hanno a disposizione opzioni terapeutiche standard

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the efficacy of pemigatinib in participants in Cohort A

Determinare l’efficacia di pemigatinib in partecipanti nella Coorte A

E.2.2

Secondary objectives of the trial

1. To evaluate the efficacy of pemigatinib in participants in Cohort B
2. To evaluate the efficacy of pemigatinib in Cohort A
3. To assess safety and tolerability of pemigatinib in all participants

1. Valutare l’efficacia di pemigatinib in partecipanti nella Coorte B
2. Valutare l’efficacia di pemigatinib nella Coorte A
3. Valutare la sicurezza e la tollerabilità di pemigatinib in tutti i partecipanti

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Age 18 years or older, inclusive at the time of signing the ICF.
2. Histologically or cytologically confirmed advanced or metastatic NSCLC (Stage IIIB/C or IV per the AJCC Cancer Staging Manual, 8th Editiion). Both squamous and nonsquamous NSCLC are eligible.
3. Radiographically measurable disease (per RECIST v1.1). Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
4. Documentation of known/likely actionable known or likely FGFR1-3 alterations.
5. Must have objective documented progression after at least 1 prior therapy, and must have no therapy available that is likely to provide clinical benefit. Participants who are intolerant of or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
6. ECOG performance status of 0 to 2.
7. Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or
metastasis.
8. Willingness to avoid pregnancy or fathering children based on the criteria below.
a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days (a spermatogenesis cycle) after the last dose of study drug and must refrain from donating sperm during this period. Permitted
methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
b. Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 30 days (1 menstrual cycle) after the last dose of study drug and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy should be communicated to the participants and their understanding confirmed.
c. A female participant not considered to be of childbearing potential is eligible.

1. Età pari o superiore a 18 anni al momento della firma dell’ICF.
2. NSCLC avanzato o metastatico confermato istologicamente o citologicamente (stadio IIIB/C o IV secondo l’Atlante di stadiazione dei tumori maligni AJCC, VIII Edizione). Sono idonei sia l’NSCLC squamoso sia quello non squamoso.
3. Malattia misurabile radiograficamente (secondo i criteri RECIST v1.1). Le lesioni tumorali situate in una zona precedentemente irradiata o in una zona sottoposta ad altra terapia locoregionale sono considerate misurabili se la progressione è stata chiaramente dimostrata nella lesione.
4. Documentazione di alterazioni azionabili note/probabili, note o probabili di FGFR1-3.
5. Deve presentare una progressione obiettiva documentata dopo almeno 1 precedente terapia e non deve essere disponibile alcuna terapia in grado di fornire un beneficio clinico. I partecipanti intolleranti o che rifiutano la terapia approvata sono idonei solo se non è disponibile alcuna terapia in grado di fornire un beneficio clinico.
6. Stato prestazionale ECOG compreso tra 0 e 2.
7. Campione tumorale di archivio al basale (di non più di 24 mesi dalla data dello screening) o disponibilità a sottoporsi a una biopsia tumorale pre-trattamento per ottenere il campione. Deve essere un blocchetto di tessuto tumorale o circa 15 vetrini non colorati acquisiti dalla biopsia o dalla resezione del tumore primitivo o della metastasi.
8. Disponibilità a evitare gravidanze o il concepimento di figli in base ai seguenti criteri.
a. I partecipanti di sesso maschile potenzialmente fertili devono accettare di adottare le dovute precauzioni per evitare di concepire figli dal momento dallo screening fino a 90 giorni (un ciclo di spermatogenesi) dopo l’ultima dose del farmaco dello studio e devono astenersi dalla donazione di sperma durante questo periodo. I metodi consentiti per prevenire le gravidanze devono essere comunicati ai partecipanti e la loro comprensione deve essere confermata.
b. Le partecipanti di sesso femminile in età fertile devono presentare un test di gravidanza sul siero negativo allo screening e un test di gravidanza sulle urine negativo prima della prima dose del Giorno 1 e devono accettare di adottare le dovute precauzioni per evitare una gravidanza dal momento dallo screening fino a 30 giorni (1 ciclo mestruale) dopo l’ultima dose del farmaco dello studio e devono astenersi dalla donazione di ovociti durante questo periodo. I metodi consentiti per prevenire le gravidanze devono essere comunicati ai partecipanti e la loro comprensione deve essere confermata.
c. È ammessa la partecipazione a donne non considerate in età fertile.

E.4

Principal exclusion criteria

1. Prior receipt of a selective FGFR inhibitor.
2. Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before the first dose of pemigatinib. Participants must have recovered (= Grade 1 as per CTCAE v5.0 or at pretreatment baseline) from AEs from previously administered therapies
(excluding alopecia).
3. Concurrent anticancer therapy (eg, chemotherapy, immunotherapy, biologic therapy, hormonal therapy, or investigational therapy).
4. Candidate for potentially curative surgery.
5. Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to macular/retinal degeneration, diabetic retinopathy, and retinal detachment) as confirmed by ophthalmologic examination.
6. Radiation therapy administered for the treatment of cancer lesions within 2 weeks before enrollment/first dose of study drug. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 1-week washout is permitted for palliative radiation to non-CNS disease.
7. Untreated brain or CNS metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). Participants who have previously treated and clinically stable brain or
CNS metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and if they are on a stable or decreasing dose of corticosteroids for at least 1 week.
8. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
9. Participants with laboratory values at screening defined in Table 5.

1. Aver ricevuto in precedenza un inibitore selettivo di FGFR.
2. Aver ricevuto farmaci antitumorali o farmaci sperimentali per qualsiasi indicazione o motivo nei 28 giorni precedenti la prima dose di pemigatinib.
I partecipanti devono essersi ristabiliti (grado =1 secondo i Criteri di terminologia comuni per gli eventi avversi (CTCAE) v5.0 o al pre-trattamento al basale) dagli eventi avversi (EA) dovuti a terapie somministrate in precedenza (esclusa alopecia).
3. Terapia antitumorale concomitante (ad es. chemioterapia, immunoterapia, terapia biologica, terapia ormonale o terapia sperimentale).
4. Candidato/a per chirurgia potenzialmente curativa.
5. Evidenza attuale di patologia corneale (inclusi, ma non limitati a cheratopatia bollosa/a fascia, abrasione corneale, infiammazione/ulcerazione, cheratocongiuntivite) o retinica (inclusi, ma non limitati a degenerazione maculare/retinica, retinopatia diabetica e distacco di retina) clinicamente significative come confermato mediante esame oftalmologico.
6. Radioterapia somministrata per il trattamento di lesioni tumorali nelle 2 settimane precedenti l’arruolamento/la prima dose di farmaco dello studio. I partecipanti devono essersi ristabiliti da tutte le tossicità correlate alle radiazioni, non devono necessitare di corticosteroidi e non devono presentare polmonite da radiazioni. Un’evidenza di fibrosi entro un campo di radiazione dalla precedente radioterapia è consentita previa approvazione del responsabile del monitoraggio medico. È consentito un washout di 1 settimana per radioterapia palliativa per malattia non a carico del sistema nervoso centrale (SNC).
7. Metastasi cerebrali o al SNC non trattate o metastasi cerebrali o al SNC che hanno manifestato una progressione (ad es. evidenza di metastasi cerebrali nuove o in accrescimento o nuovi sintomi neurologici attribuibili alle metastasi cerebrali o al SNC).
I partecipanti con metastasi cerebrali o al SNC precedentemente trattate e clinicamente stabili sono idonei se non vi è alcuna evidenza di progressione per almeno 4 settimane dopo il trattamento diretto al SNC, come accertato mediante esami clinici e diagnostica per immagini (RMI o TAC) cerebrali durante il periodo di screening e se in trattamento con una dose stabile o decrescente di corticosteroidi per almeno 1 settimana.
8. Altro tumore maligno noto che sia in progressione o che richieda un trattamento attivo. Le eccezioni comprendono carcinoma basocellulare, carcinoma squamocellulare o tumore della cervice uterina in situ che sia stato sottoposto a terapia potenzialmente curativa.
9. Partecipanti con valori di laboratorio allo screening come definiti nella Tabella 5.

E.5 End points

E.5.1

Primary end point(s)

ORR in Cohort A, defined as the proportion of participants who achieve a CR or PR based on RECIST v1.1. Response will be determined by an ICR review.

ORR nella Coorte A, definito come la percentuale di partecipanti che ottengono una CR o PR in base ai criteri RECIST v1.1. La risposta sarà determinata mediante una revisione ICR.

E.5.1.1

Timepoint(s) of evaluation of this end point

The schedule for assessments will be performed according to the schedule of activities reported in the protocol.
Adverse events will be monitored from the time the participant signs the ICF until at least 30 days after the last dose of study drug or until the start of new anticancer therapy.

Il programma delle valutazioni sarà svolto secondo il programma delle attività indicato nel protocollo.
Gli eventi avversi saranno monitorati dal momento in cui il/la partecipante firma il modulo di consenso informato (ICF) fino ad almeno 30 giorni dopo l’ultima dose del farmaco dello studio o fino all’inizio di una nuova terapia antitumorale.

E.5.2

Secondary end point(s)

• ORR in Cohort B, defined as the proportion of participants who achieve a CR or PR based on RECIST v1.1. Response will be determined by an ICR review.
• PFS in Cohort A, defined as the time from the first dose of study drug until PD (according to RECIST v1.1 as assessed by an ICR review) or death, whichever is first.
• DOR in Cohort A, defined as the time from the date of the first CR or PR until the date of the first PD (according to RECIST v1.1 as assessed by an ICR review) or death, whichever is first.
• OS in Cohort A, defined as the time from the first dose of study drug to death of any cause.
• Safety and tolerability, as assessed by the occurrence of TEAEs and treatment-related TEAEs according to NCI CTCAE v5.0, physical examination changes, vital sign changes, laboratory evaluations, and ECGs.

• ORR nella Coorte B, definito come la percentuale di partecipanti che ottengono una CR o PR in base ai criteri RECIST v1.1. La risposta sarà determinata mediante una revisione ICR.
• PFS nella Coorte A, definita come l’intervallo di tempo che va dalla prima dose del farmaco dello studio fino alla PD (in base ai criteri RECIST v1.1, come valutato mediante una revisione ICR) o fino al decesso, a seconda di quale evento si verifichi per primo.
• DOR nella Coorte A, definita come l’intervallo di tempo trascorso dalla data della prima CR o PR alla data della prima PD (secondo i criteri RECIST v1.1, come valutato mediante una revisione ICR) o fino al decesso, a seconda di quale evento si verifichi per primo.
• OS nella Coorte A, definita come il tempo trascorso dalla prima dose di farmaco dello studio al decesso per qualsiasi causa.
• Sicurezza e tollerabilità, valutate in base all’insorgenza di TEAE in base ai Criteri comuni di terminologia per gli eventi avversi (CTCAE) del National Cancer Institute (NCI) v5.0, alle variazioni all’esame obiettivo, alle variazioni nei segni vitali, alle valutazioni di laboratorio e agli ECG.

E.5.2.1

Timepoint(s) of evaluation of this end point

The schedule for assessments will be performed according to the schedule of activities reported in the protocol

Il programma delle valutazioni sarà svolto secondo il programma delle attività indicato nel protocollo

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

in aperto

open

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

France

Germany

Italy

Spain

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

125

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Upon completion of this study, for participants who are continuing to receive study drug and benefiting from treatment with pemigatinib, the rollover study, INCB 54828-801, is available.

Al completamento di questo studio, per i partecipanti che stanno continuando a ricevere il farmaco dello studio e che stanno traendo benefici dal trattamento con pemigatinib, è disponibile lo studio di rollover, INCB 54828-801.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-03-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-03-17

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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